Oxcarbazepine Plus Morphine in Patients With Refractory Cancer Pain



Status:Recruiting
Conditions:Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:4/21/2016
Start Date:February 2014
End Date:January 2017
Contact:Anne Younger, R.N
Email:anefoste@iupui.edu
Phone:317-274-0951

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A Phase Ib Study of Oxcarbazepine Plus Morphine in Patients With Refractory Cancer Pain

This is an open-label, single arm, Phase Ib dose escalation study of Oxcarbazepine with
morphine in patients with refractory cancer pain. The primary endpoint is to evaluate the
safety and toxicity of the combination of Oxcarbazepine plus morphine. The secondary
endpoints are improving pain control, reduce morphine use and improve the quality of life.


Inclusion Criteria:

- Written informed consent and HIPAA authorization for release of personal health
information.

•≥ 18 years old at the time of informed consent

- Patients with histologically confirmed diagnosis of cancer NOTE: Patients with active
cancer or post treatment are allowed on the study.

- Patients must be receiving stable or increasing doses of morphine for 1-2 weeks prior
to registration for protocol therapy.

NOTE: Switching patient from current pain regimen to morphine equivalent for at least 1-2
weeks prior to registration for protocol therapy is required.

- Requiring greater than or equal to 180 mg of morphine per day. See Appendix 1 for
Morphine Conversion Calculator.

- Inadequately controlled pain even with the use of morphine (VAS score >5) See
Appendix 8

- Rescue pain medications are allowed this may include the use of NSAIDS or Tylenol as
well as morphine IR.

- ECOG Performance Status of 0-2

- Ability to swallow and tolerate oral tablets.

- Patients getting radiation therapy are allowed at the discretion of the treating
physician.

- Females of childbearing potential must have a negative pregnancy test NOTE: Females
are considered of child bearing potential unless they are surgically sterile (they
have undergone a hysterectomy, bilateral tubal ligation, or bilateral oophorectomy)
or they are postmenopausal (> 12 months since last menses).

NOTE: Females using hormonal contraceptives should be switched to non-hormonal forms of
contraception.

The following laboratory values must be obtained. Patient with aplastic anemia will be
excluded.

- White blood cell count (WBC) ≥ 3.0 K/mm3

- Absolute neutrophil count ≥ 1.5 K/mm3

- Hemoglobin (Hgb) ≥ 9 g/dL

- Platelets ≥ 75 K/mm3

- Creatinine ≤ 1.5 mg/dl

- Bilirubin ≤ 1.5 x ULN

- Aspartate aminotransferase (AST, SGOT) ≤ 3 x ULN

- Alanine aminotransferase (ALT, SGPT) ≤ 3 x ULN

Exclusion Criteria:

• Active central nervous system (CNS) metastases. Patients with neurological symptoms
should undergo a head CT scan or brain MRI to exclude brain metastasis, at the discretion
of the treating physician.

NOTE: Patients with prior brain metastasis may be considered if they have completed their
treatment for brain metastasis, no longer require corticosteroids, and are asymptomatic.

• Concurrent use of adjuvant medication such as but not limited to: gabapentin, pregabalin
or duloxetine etc.

NOTE: Patients on gabapentin or pregabalin can be considered if they can be tapered off
before enrolling on the study.

- Treatment with any investigational agent within 30 days prior to registration for
protocol therapy.

- Patient with rapidly escalating pain that require hospitalization or an intravenous
opioid therapy

- Concurrent participation in a clinical trial which involves another investigational
agent.

- Concurrent use of medications that are strong CYP3A4 inhibitors within 14 days prior
to registration for protocol therapy as Oxcarbazepine is strong CYP3A4 inducer. See
Appendix 7.

NOTE: Concurrent use of other CYP3A4 inhibitors may be allowed at the discretion of the
treating physician or principal investigator.

- Allergic reaction to carbamazepine or oxcarbazepine (HLA-B1502)

- Allergy or other contraindication to morphine sulphate

- Opiate-induced uncontrolled constipation or bowel obstruction

- Patient who lives alone.

- Female who is pregnant or breastfeeding

- Patient who has a diagnosis of epilepsy and/or is currently taking anti-epileptic
drugs
We found this trial at
2
sites
Indianapolis, Indiana 46202
Principal Investigator: Costantine Albany, M.D.
Phone: 317-274-0951
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Indianapolis, Indiana 46202
Principal Investigator: Costantine Albany, M.D.
Phone: 317-274-0951
?
mi
from
Indianapolis, IN
Click here to add this to my saved trials